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FDA 510(k)

TT1 GENERAL PURPOSE COIL

K-Number: K083434 · 2008-12-23

ApplicantTursiop Technologies, LLC
Decision Date2008-12-23
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TT1 GENERAL PURPOSE COIL is the device name listed in this FDA 510(k) record. The listed applicant is Tursiop Technologies, LLC. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K083434. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TT1 GENERAL PURPOSE COIL?

TT1 GENERAL PURPOSE COIL is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is Tursiop Technologies, LLC. The 510(k) number is K083434.

When did TT1 GENERAL PURPOSE COIL receive FDA 510(k) clearance?

TT1 GENERAL PURPOSE COIL received FDA 510(k) clearance on 2008-12-23, under 510(k) number K083434.

Who is the listed applicant for TT1 GENERAL PURPOSE COIL?

The FDA 510(k) record lists Tursiop Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TT1 GENERAL PURPOSE COIL?

The FDA product code for TT1 GENERAL PURPOSE COIL is MOS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Tursiop Technologies, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113280CAROTID COIL GE 1.5T

Related Devices (Code: MOS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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